FDA recall, , Moderate risk
C-RAD Catalyst+ Patient Positioning Devices
The Catalyst and Catalyst+ patient positioning device may show a patient as correctly positioned even when the isocenter is outside tolerance.
Summary by Recall Canary from the FDA notice
What happened
C-RAD POSITIONING AB of Uppsala, Sweden, is recalling the Catalyst and Catalyst+ patient positioning devices due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups.
In certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance. The recall began on October 9, 2025, and was added to the FDA's Enforcement Report on January 14, 2026. The software module cSRS has been installed in 37 countries worldwide, including the United States in 18 states.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number is listed.
Catalyst, Catalyst+
- Model number
- SP001-0026
- SP003-0002
Recall details
- Company began the recall
- Sold in
The software module cSRS has been installed in 37 countries Worldwide - U.S. Nationwide distribution in the states of Alaska, Alabama, Arkansas, California, Connecticut, Florida, Missouri, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, and Washington. The countries of Argentina, Australia, Austria, Belarus, Belgium, Benin, Canada, China, Colombia, Egypt, El Salvador, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Mexico, Morocco, Netherlands, New Zealand, Norway, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, and Vietnam.
- Company
- C-RAD POSITIONING ABUppsala, Sweden
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97872
- Recall number
- Z-1092-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
